Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00962767

Enrollment

168

Registered

2009-08-20

Start date

2002-05-31

Completion date

2007-12-31

Last updated

2009-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelocytic, Acute

Keywords

Oncology comparison study

Brief summary

The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.

Interventions

DRUGgemtuzumab ozogamicin

2 IV infusions 6 mg/m2 administered monthly

DRUGATRA plus 6-MP and MTX

6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 61 Years

Healthy volunteers

Inclusion criteria

1. Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease. 2. Male and female patients age \> 18 years and \< 61 years.

Exclusion criteria

1. Low risk patients (WBC \< 10 x 109/L and platelets \> 40 x 109/L). 2. Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene. 3. Pretreated APL.

Design outcomes

Primary

Measure	Time frame
The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission.	5 years

Secondary

Measure	Time frame
Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival.	5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026